Part 1 What does my participation involve?

1 Introduction

You are invited to take part in this research project, which is called TRIBE-pilot, a study aiming to test acceptability and feasibility of a new technology-based self-help intervention for people with bipolar II disorder. The intervention integrates an online self-help program with companion smartphone App designed to improve symptoms and quality of life for people with bipolar II disorder. The project is based in Australia, with participants taking part from Australia as well as worldwide.

This Participant Information Sheet/Consent Form tells you about the research project. It explains the processes involved with taking part. Knowing what is involved will help you decide if you want to take part in the research.

Please read this information carefully. If you have any questions about anything that you don’t understand or want to know more about, please contact the research team by clicking on the “Contact us” button at the bottom of the page. Before deciding whether or not to take part, you might want to talk about it with a relative, friend or local health worker.

Participation in this research is voluntary. If you don’t wish to take part, you don’t have to.

If you decide you want to take part in the research project, you will be asked for your consent on the following page by clicking “NEXT PAGE”. By clicking “NEXT PAGE” you are telling us that you:

Understand what you have read

Consent to take part in the research project

Consent to be involved in the research described

Consent to the use of your personal and health information as described.

A copy of this Participant Information and Consent Form will be emailed to the account you nominate when you create your account on the TRIBE website.

2 What is the purpose of this research?

Bipolar II disorder (BD-II) can be a serious mental health condition. Despite modern drug and psychological treatments, many continue to experience frequent hypomanic and depressive relapses. The aim of this study is to improve outcomes in BD-II by a new online self-help program with smartphone companion App specifically designed for people who experience BD-II.

Our international team of researchers, clinicians and consumers has developed a brief intervention (3 weeks total involvement), using cutting-edge technologies and design features to help people engage with the therapeutic content and generalise it into their real lives.

This research is being conducted by a collaborative group of international researchers, coordinated by Swinburne University in Australia.

The results of this research will also be used by the student investigator Ms Summer Guo to obtain her PhD degree.

3 What does participation in this research involve?

If you consent to participate in this project, and meet our inclusion criteria (see below), you will be participating in a research project over a period of 3 weeks.

The intervention

The self-help program will involve access to a website with information designed to improve symptoms and quality of life in bipolar II disorder. The website include exercises, videos and downloadable content. For the 3 weeks of the intervention, you will also have access to a companion smartphone App to help you track your mood and practice new skills in your everyday life. The materials have been designed to be interesting and empowering, and exercises involve watching videos, reflecting on your own experiences, and practicing new skills in your everyday life.

We expect people during the 3-week intervention period to visit the website daily, use the smartphone App twice daily, and be actively involved in the intervention (either by viewing material on the website, using the smartphone App or practicing skills ‘in the real world’) for about 2-3 hours per week.

Your website usage data and companion smartphone App data will be used for research purposes.

Assessments

If you agree to participate in the research, you will be contacted by the research team to arrange a telephone interview where you will be asked about your mental health history and symptoms (‘baseline assessment’). This interview may take up to 2 hours. You will then be asked to complete some online questionnaires about your background, symptoms and broader well-being which will take up to 1 hour. These can be done on separate days. After completion of the baseline assessment you will get access to the website content and smartphone App.

You will also be asked to take part in one follow-up assessment session for which there is a telephone component and an online component one week after you have completed the intervention. The follow-up assessment may take up to 1 hour on the phone and up to 1 hour online. Participants who complete all assessments (phone and online assessment components at baseline and follow-up) will be reimbursed with a gift card ($50 USD which can be used world wide). There is a 2-week window for completion of both parts of the assessment and we ask that you make yourself available to complete these assessments at this time. If we are unable to contact you (by email or phone) during the time your assessment is due, we will contact your alternate contact person (someone you identify who can help us contact you if necessary, e.g., a family member or friend) and/or your treating medical practitioner.

Criteria for participation

To participate in the study, you must provide us with the contact details (including phone number) of your treating medical practitioner who you have seen at least once in the last 12 months, and who will continue to care for you during your participation in this study. You must be aged 18-65; received a diagnosis of bipolar II disorder from a medical professional; have ready daily access to the internet and a smartphone. Participants cannot be in an acute episode (hypomanic or depressive episode) when they enrol in the study (but can commence participation after the episode is over).

Research Monitoring

The conduct and progress of the study will be monitored by the investigator team. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way.

Optional parts of the study

The following parts of the study are optional. You can select whether you are willing to do these below.

Feedback interview. You may also be invited to give your feedback on the TRIBE program via a telephone interview of up to 25 minutes, for which you would recieve a gift card ($25 USD which can be used world-wide). If selected, you will be asked if you would like to participate in this aspect of the research after the 3-week intervention. Audio recording of this interview is required for participation in the interview.

Use data for future research. We would also like your permission to indefinitely store and use the data we collect for this study for research projects that are not described here. This will help us to maximize the outcome of our research effort and avoid the need to reapproach you. Any project using the data will have been approved by a Human Research Ethics Committee (HREC). The data will only be used in a coded way and researchers will not have access to your personalized data.

4 Other relevant information about the research project

We are expecting up to 60 participants to take part in this pilot project. Participants will be recruited from around the world. The services on the TRIBE website and smartphone App are provided in accordance with Australian laws and health practice standards. You acknowledge and accept that the services may not comply with the laws and standards that apply in the jurisdiction in which you receive the services.

5 Do I have to take part in this research project?

Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.

If you do decide to take part, you will be emailed a copy of this Participant Information and Consent Form to keep.

Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine care, your relationship with professional staff or investigators on the project or your relationship with Swinburne University or other Investigator organisations.

6 What are the possible benefits of taking part?

We cannot guarantee or promise that you will receive any benefits from this research; however, you will be assisting in the development and testing of a new online self-help program and smartphone App that we hope are useful to people with bipolar II disorder. You may also find that, by undertaking the intervention, your symptoms and quality of life improve.

7 What are the possible risks and disadvantages of taking part?

Discomfort or distress

If you agree to participate in this research, you will be asked questions during assessments about your mental health. In general, it is not anticipated that discussion of these topics would give rise to any negative effects. However, where experiences have been of a traumatic or difficult nature, there may be a small possibility that recalling these events may cause you to feel upset or distressed. You will also be exploring therapeutic content. As with any psychological therapy, there is the risk that you experience some discomfort or even distress by reflecting on your own coping styles and by learning and practicing new ways of behaving. We have conducted a pilot study of this intervention, adjusted some content based on feedback from people with bipolar disorder, and flagged exercises that might be particularly challenging for some people.

If you do feel distressed when being interviewed, answering questions online, or during the intervention, please let the research team know. If you feel uncomfortable with any aspect of your participation, you are free to indicate at any time that you don’t want to do/answer/talk about that, to have a break, or to discontinue your participation.

At the beginning, we will ask you to give us the contact details of your local medical practitioner (general practitioner/doctor or psychiatrist) who is not involved in this project. This is so that if you wanted any further support during your participation in the research, you know you can speak to that person. If we had any concerns about you, we would also encourage you to speak to that person and we could help you to do that.

This program is not a substitute for medication, and does not replace your usual medical care. Because this is an international online intervention, we are not able to take on the responsibility for your health care or well-being. There is no emergency assistance available through the website, which is not monitored across all the timezones that participants are coming from.

We offer this intervention as an added extra to your usual care. You must have sought assistance from a medical practitioner in the last 12 months to participate in this program. If you have suicidal thoughts, seek immediate assistance from your medical practitioner or emergency department.

Other risks

During the research project, if new information about the risks and benefits of the project became known to the researchers, you would be told about this new information and one of the researchers would discuss whether this new information affects you.

8 What if I withdraw from this research project?

If you do consent to participate, you may withdraw at any time. If you decide to withdraw from the project, please notify a member of the research team. If you do not tell a member of the research team you wish to withdraw, we will continue to attempt to contact you (and your nominated contact people) for the follow-up assessment. A member of the research team will inform you if there are any special requirements linked to withdrawing during a withdrawal phone call.

If you decide to leave the research project, the researchers will not collect additional personal information from you, although personal information already collected will be retained to ensure that the results of the research project can be measured properly and to comply with law. You should be aware that data collected up to the time you withdraw will form part of the research project results. If you do not want your data to be included, you must tell the researchers when you withdraw from the research project.

9 What happens when the research project ends?

We expect to publish the results of this study when it is completed at the end of 2019. Scientific findings will be published in scientific journals. Outcomes relevant to practitioners will be disseminated through our training and professional networks. Participants will also receive (via email) an overview of the study’s findings. In all types of publication, only group data will be presented and no individuals will be identified. Following Australian Health Data regulations, all data will be securely held during the study and for 7 years post publication of the study findings.

Part 2 How is the research project being conducted?

10 What will happen to information about me?

Confidentiality

It is a requirement of your participation that you provide the contact details of your medical practitioner. By signing the consent section, you agree to them being notified of your participation in the project. We may also inform your designated medical practitioner if we were concerned about your immediate safety or that of others. As noted above, the website is not a replacement for your usual clinical care, and you cannot access emergency assistance through the site. However, we might become concerned about your safety because you might mention a risk (e.g., suicidal plans) in one of the assessment interviews or in your responses to an online questionnaire. If we come to believe that you are at immediate risk of harming yourself, we will go through a series of steps to try to manage this risk. Depending on the circumstances, we may contact you personally via email and encourage you to contact your medical practitioner or visit the emergency room. If we don’t hear back from this email, we would then try to contact you by phone. If we can’t reach you by phone, we would then contact your medical practitioner by phone. In some rare situations, we may attempt to speak to you by phone to ensure that you are safe, and this safety planning may include encouraging you to contact your medical practitioner or emergency services, or us making that contact for you.

You will also be given the option of naming a carer/partner/friend who we can contact if we cannot contact you at the time an assessment is due (this may be the same person or someone different). This person/people would therefore know that you are participating in the study.

With these exceptions, any information obtained in connection with this research project that can identify you will remain confidential. It will only be disclosed with your permission, except as required by law. Your name will not be used and all participants will be identified by a code number. Only the researchers involved in the study will have access to the information.

Security

The information that we collect from you as part of this research project outside of the website, will be stored securely in the National eTherapy Centre (NeTC) at Swinburne University for a minimum period of seven years. The website itself is hosted on a secure server, and will be maintained with best practice security standards.

The NeTC does its utmost to protect its website platform from security breaches. NeTC online websites have a security certificate, which means they comply with the security requirements of a certification authority. However, the provision of services through NeTC websites are subject to security risks inherent in any internet service. Whilst the NeTC endeavours to ensure that personal information is secure, it is not possible to safeguard against all possible breaches of security. Participants are advised to ensure that the computer terminal from which you send messages and access the website is secure and to ensure that you log out of the website after you have finished a session on it. Your website usage data and companion smartphone App (MoodPrism) data will be used for research purposes. The companion smartphone App (MoodPrism) has an established privacy policy outlining confidential and secure data collection and storage (http://www.moodprismapp.com/privacypolicy/).

Publications

We hope that the findings from this project will be presented in scientific journals and at scientific conferences. Some data from this project will also be used for the purposes of a PhD project. In any publication, information will be provided in such a way that you cannot be identified.

Accessing information about you

In accordance with relevant Australian privacy and other relevant laws, you have the right to access the information collected and stored by the researchers about you. You also have the right to request that any information, with which you disagree, be corrected. Please contact one of the researchers named at the end of this document if you would like to access your information.

11 Complaints and compensation

If you suffer any distress or psychological injury as a result of this research project, you should contact the research team and your health professional as soon as possible. You will be assisted with arranging appropriate treatment and support.

12 Who is organising and funding the research?

Funding

This research is being funded through Swinburne University of Technology research accounts held by Professor Greg Murray.

Co-ordination

It is being co-ordinated by Swinburne University in Australia, working in partnership with a team of international researchers.

Commercialisation

Although not planned at this time, it is possible that in the future Swinburne University and/or the researchers may seek to commercialise intellectual property arising from this research. You will not benefit financially from your involvement in this research project even if, for example, knowledge acquired from your participation proved to be of commercial value. In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to the researchers or their institutions, there will be no financial benefit to you or your family from these discoveries.

No member of the research team will receive a personal financial benefit from your involvement in this research project (other than ordinary wages).

13 Who has reviewed the research project?

All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC).

The ethical aspects of this research project have been approved by the HREC of Swinburne University.

This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies.

14 Further information and who to contact

The person you may need to contact will depend on the nature of your query. If you want any further information concerning this project or if you have any problems which may be related to your involvement in the project, you can contact the following people: